Abstract
The objective of this study was to conduct a literature review comparing oral brand-name and generic drugs used for arrhythmia and to summarize the relevant clinical evidence.
Using the PubMed and Ichushi databases, we searched for articles comparing brand-name and generic drugs and categorized them according to the Vaughan Williams classification. For assessment, we divided the articles into affirmative and unfavorable groups according to the authors' positions concerning generic substitution. In addition, we evaluated the evidence levels of the articles.
Twenty articles were reviewed in this study, of which 14 were classified as affirmative and six as unfavorable. Of the affirmative articles, one was graded as evidence level I and six as evidence level II. Among the unfavorable articles, one was graded as evidence level II, four as evidence level V, and one as evidence level VI; no articles were graded as evidence level I. The affirmative articles included an evidence level I study report on drugs used for cardiovascular disease such as β-blockers; this evidence level demonstrates a significantly high level for articles pertaining to clinical efficacy and safety. Unfavorable articles tended to have lower evidence level than affirmative articles because many of these articles were case reports with a small number of subjects or descriptive studies, without details regarding the study methods and patients.
